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BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug for Lung Biopsy

Phase 3

Waitlist Available

Led By Majid Maybody, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours post procedure

Awards & highlights

Study Summary

This trial is comparing two techniques to close a hole in the lung after a biopsy. One uses a person's own blood, the other a gel plug.

Eligible Conditions

Lung Biopsy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the Rate of Pneumothorax

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BioSentry (formerly known as Bio-Seal) hydrogel Tract PlugExperimental Treatment1 Intervention

Group II: autologous blood patch injection (ABPI)Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug

2014

Completed Phase 3

~460

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,427 Total Patients Enrolled

Majid Maybody, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Amgad Moussa, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared BioSentry's hydrogel Tract Plug for use?

"BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug is a Phase 3 medical device, meaning that there is both data supporting its efficacy and multiple rounds of safety data. Our team rates the safety of this product as a 3."

Answered by AI

Are you still looking for people to participate in this clinical trial?

"This study, as indicated by clinicaltrials.gov, is no longer recruiting patients for participation. However, there are 18 other similar trials that are currently looking for participants."

Answered by AI

Recent research and studies

RadiologyJournal

Autologous Blood Patch Injection Versus Hydrogel Plug in Ct-guided Lung Biopsy: A Prospective Randomized Trial

Maybody, Majid, Nadim Muallem, Karen T. Brown, Chaya S. Moskowitz, Meier Hsu, Christina L. Zenobi, Marwah Jihad, et al.. 2019. “Autologous Blood Patch Injection Versus Hydrogel Plug in Ct-guided Lung Biopsy: A Prospective Randomized Trial”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiol.2018181140.

clinicaltrials.govStudy

Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures

2014. "Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02224924.